FDA 510(k)

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P

Numéro K : K253277 · 2026-07-24

DemandeurGe Medical Systems Information Technologies, Inc.

Date de décision2026-07-24

Code produitMHX

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2026-07-24 under 510(k) number K253277. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P?

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P is a medical device that received FDA 510(k) clearance on 2026-07-24. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K253277.

When did Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P receive FDA 510(k) clearance?

Moniteur B105M; Moniteur B125M; Moniteur B155M; Moniteur B105P; Moniteur B125P ont reçu l'approbation 510(k) de la FDA le 2026-07-24, sous le numéro 510(k) K253277.

Who is the listed applicant for Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P?

The FDA 510(k) record lists Ge Medical Systems Information Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P?

The FDA product code for Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P is MHX.

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Autres dossiers indiquant Ge Medical Systems Information Technologies, Inc. en tant que demandeur

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Source officielle

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